Distribution of infusion pumps

ABSTRACT

Some embodiments described herein provide for a number of portable infusion pumps to be distributed to a pump user via a pharmacy system or like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/369,534, filed on Feb. 11, 2009, which claims priority under 35 USC§119(e) to U.S. Provisional Patent Application Ser. No. 61/027,869,filed on Feb. 12, 2008. The complete contents of these earlierapplications are hereby incorporated by reference.

TECHNICAL FIELD

This document relates to portable infusion pump systems to deliverfluids, such as insulin infusion pumps or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood-glucose levels.

Some infusion pumps are provided to users as “durable medical equipment”that is intended to be used for many consecutive years. As such, theupfront costs of obtaining such an infusion pump are high. In somecircumstances, a user's health insurance provider will pay a substantialportion of these upfront costs. However, the process for preauthorizinginsurance coverage for an infusion pump (under the “durable medicalequipment” procedure) may require a substantial burden of paperwork andcommunications among the pump supplier, the physician who prescribes theinfusion pump for the user, and the user's health insurance provider.

SUMMARY

Some embodiments described herein provide for a number of portableinfusion pumps to be distributed to a pump user via a pharmacy system ora like process that may impose a lower burden on the pump user whenobtaining the infusion pump. In such circumstances, a pump user maysimply pay a co-pay at the pharmacy window, and then take home a newsupply of infusion pumps for use in dispensing a medicine (e.g., insulinor another infused medication) over a period of time. Accordingly, thepaperwork burdens imposed upon the pump supplier and the physiciantreating the user may be reduced, and the delays associated withobtaining preauthorization for insurance coverage can also be reduced oreliminated. Furthermore, this distribution system may provide relief tohealth insurance providers by spreading the costs for the infusion pumpusage over a longer period of time (rather than paying a large upfrontcost for an infusion pump distributed as durable medical equipment).

In particular, embodiments, a method of receiving an insulin infusionpump device can include obtaining a prescription for a supply ofinfusion pump devices to deliver insulin. The method may also includesubmitting the prescription to a pharmacy for repeated deliveries of theinfusion pump devices over a predetermined period of time. The methodmay further include receiving a plurality of infusion pump devices fromthe pharmacy contemporaneously with the receipt of insulin frompharmacy.

Some embodiments of a method of providing an insulin infusion pumpdevice may include storing multiple infusion pump devices in a pharmacyinventory. The method may also include, in response to an individualuser request to a pharmacy for repeated deliveries of infusion pumpdevices, distributing a plurality of infusion pump devices from thepharmacy inventory to the individual user while contemporaneouslydistributing insulin from the pharmacy inventory.

In certain embodiments, a method of providing an insulin infusion pumpsystem can include selecting a predetermined ratio of disposable andnon-reusable infusion pump devices to insulin cartridges that areoperable to be received in the infusion pump devices. The predeterminedratio may one infusion pump device to one insulin cartridge. The methodmay also include arranging disposable pump devices and insulincartridges into a package according to the predetermined ratio. Themethod may further include providing the package to a requestor inresponse to a request.

In some embodiments, a method providing an insulin infusion pump systemmay include obtaining a disposable and non-reusable infusion pumpdevice, an insulin cartridge containing insulin, and at least oneinfusion set device operable to penetrate into skin. The method may alsoinclude arranging the disposable pump device, the insulin cartridge, andthe at least one infusion set device into a single package. The methodmay further include providing the single package to a requestor inresponse to a request for at least the pump device.

Some or all of the embodiments described herein may provide one or moreof the following advantages: First, a pump user can receive a supply ofportable infusion pumps in a manner that can reduce the time andpaperwork burden for the user. For example, the individual user canreceive a number of portable infusion pumps via a pharmacy system or thelike so that the pump user can simply pay a relatively small fee at thepharmacy window to obtain a supply of infusion pumps. Second, thedistribution of the infusion pumps via a pharmacy system may providebenefits to health insurance providers by spreading the costs for theinfusion pump usage over a longer period of time. For example, each ofthe infusion pumps can be a low cost and disposable component, so thecost to insurers is spread out in the form of user prescription refills,as opposed to a large up front cost. By spreading the costs over agreater period of time, the health insurance provider is not necessarilyexposed to a sunk cost in the form of the large upfront payment in theevent that the pump user decides to no longer continue pump therapy oraccidentally loses or damages the infusion pump. Third, the pharmacydistribution of the infusion pumps can reduce the substantial paperworkburdens that may otherwise be required for preauthorization of insurancecoverage for an infusion pump classified as “durable medical equipment.”In these circumstances, the paperwork burdens imposed upon the pumpsupplier and the physician treating the user may be reduced, and thedelays associated with obtaining preauthorization for insurance coveragecan also be reduced or eliminated. Fourth, one or more of the infusionpumps can be packaged along with an associated medicine cartridge tosimply the transaction for the pump user. For example, the package mayinclude a quantity of infusion pumps in a 1:1 ratio with the quantity ofmedicine cartridges. In addition, the package may include a quantity ofinfusion sets for use with one or more of the infusion pumps. In suchcircumstances, the pump user may be able to pay a single copay or otherfee to receive the package containing the infusion pumps, the medicinecartridges, and other components.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a diagram of distributing infusion pumps in accordance withsome embodiments.

FIG. 2 is a perspective view of an infusion pump system in accordancewith some embodiments.

FIG. 3 is a perspective view of an infusion pump system in accordancewith particular embodiments.

FIG. 4 is a perspective view of the infusion pump system worn onclothing of a user, in accordance with some embodiments.

FIG. 5 is a perspective view of an infusion pump system worn on skin ofa user, in accordance with particular embodiments.

FIGS. 6-7 are perspective views of a pump device being detached from acontroller device, in accordance with some embodiments.

FIGS. 8-9 are perspective views of the pump device of FIGS. 6-7 beingdiscarded and the controller device of FIGS. 6-7 being reused with a newpump device.

FIGS. 10-11 are perspective views of the new pump device of FIG. 8 beingattached to the controller device of FIG. 8.

FIG. 12 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 13 is a perspective view of a pump device (with a housing portionremoved) for an infusion pump system, in accordance with someembodiments.

FIG. 14 is a flow diagram depicting the distribution of infusion pumpsfrom the perspective of a user, in accordance with some embodiments.

FIG. 15 is a flow diagram depicting the distribution of insulin pumpsfrom the perspective of a pharmacy, in accordance with some embodiments.

FIG. 16 depicts the contents of an infusion pump kit prior to packaging,in accordance with some embodiments.

FIG. 17 is a perspective view of the infusion pump kit depicted in FIG.16 after packaging, in accordance with some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some embodiments described herein enable an infusion pump user to obtaina supply of portable infusion pumps in a manner that can reduce the timeand paperwork burden for the user. In particular, a number of portableinfusion pumps to be distributed to the individual user via a pharmacysystem or the like so that the pump user can simply pay a relativelysmall fee at the pharmacy window to obtain a supply of infusion pumpswithout burdensome applications, reimbursement requests, or othertime-consuming paperwork. Also, the pump user may experience less delaybetween the time of the prescription and the time of starting pumptherapy because the paperwork burdens normally imposed upon the pumpsupplier and the treating physician (e.g., paperwork required forpreauthorization of “durable medical equipment”) may be eliminated orreduced. Furthermore, the distribution methods described herein mayprovide relief to health insurance providers by spreading the costs forthe infusion pump usage over a longer period of time.

For example, some processes described herein permit an individual toobtain one or more infusion pumps and associated components (e.g.,medicine cartridges, infusion sets, and the like) in a convenient mannerat a single location during a single visit. In particular embodiments, apump user can obtain a set of infusion pumps, medicine cartridges thatcorrespond to the infusion pumps, and other components from a pharmacy(e.g., a brick and mortar establishment, or direct order system) byproviding the pharmacy with information related to the individual'sinsurance and providing the pharmacy with a copay payment. The infusionpumps may be, in some embodiments, disposable and non-reusablecomponents that made available to the pump user from the pharmacy at thesame time that medicine cartridges are obtained. Optionally, the entirepackage can be obtained using a single copay payment. In this manner, anindividual can travel to a pharmacy, present a prescription andinsurance card, complete a single payment transaction, and therebyreceive one or more infusion pumps and other components for use in awearable infusion pump system. In another example, an individual couldreceive the infusion pumps, medicine cartridges, and other componentsvia a direct pharmacy order system. In this case, as with the pharmacyvisit, a lower paperwork burden is imposed on the individual requestingthe infusion pumps, but also has the additional advantage of having thecomponents shipped directly to the individual's address. In thesescenarios, health insurance providers can also benefit. For example, insome embodiments the infusion pump can be a low cost and disposablecomponent, so the cost to insurers is spread out over a greater periodof time (e.g., in the form of refills), as opposed to a large up frontcost. Thus, the risks to the health insurance provider can be reduced.If, for example, the pump user decides to no longer continue pumptherapy or accidentally loses or damages the infusion pump, the healthinsurance provider is not necessarily exposed to a sunk cost in the formof the large upfront payment.

Referring now to FIG. 1, in some embodiments of an infusion pumpdistribution system 50 a customer 52 (e.g., a pump user or the like)submits information to a pharmacy 60. For example, the information mayinclude a medical prescription 54 from a health care professional forinfusion pumps 100. The prescription 54 can be a written prescriptionthat was previously obtained by the customer 52 from a medicalprofessional. It should be understood that, in some embodiments, theprescription 54 may include written instructions from a medicalprofessional for the use of components that do not require a formalwritten prescription. In this embodiment, the prescription 54 includesinstructions for one or more infusion pumps 100, one or more medicinecartridges 100, and one or more infusion sets 146. Optionally, thecustomer 52 may also submit information to the pharmacy 60 describinginsurance coverage, such as an insurance card 56. The insurance card 56may assist the pharmacy in determining what portion of the costs will bepaid by a covering insurance company and what portion of the cost willbe paid by the customer 52 in the form of a copay payment. Upon receiptof the information from the user 52, the pharmacy 60 may verify theinformation contained in one or both of the presented prescription 54and insurance card 56. For example, the pharmacy 60 can contact themedical professional who issued the prescription 54 to verify thevalidity of the prescription 54. Also, the pharmacy 60 can contact theinsurance company that issued the health insurance card 56 to determinethe existence and extent of existing coverage.

In some embodiments, after preliminary steps have been completed (e.g.,after the previously described information is submitted to the pharmacy60), a pharmacist 62 can enter into a transaction 65 with the customer52. This transaction 65 can include, for example, the payment of a copay58 (e.g., using cash, credit card, check, and the like) by the customer52 to the pharmacist 62 (e.g., a licensed pharmacist or any otheremployee of the pharmacy 60) at a pharmacy counter 66. During thetransaction 65, the pharmacist 62 can provide to the customer 52 acontainer 70 (e.g., a bag or other package) including one or moreinfusion pumps 100 (as indicated by the prescription 54) and othercomponents. In this embodiment, the infusion pump components in thecontainer 70 include two or more disposable and non-reusable pumpdevices 100 for use with a wearable insulin pump system, two or moremedicine cartridges 120, and a plurality of infusion sets 146. Also inthis embodiment, the number of medicine cartridges 120 may be providedin a 1:1 ratio with the number of infusion pumps 100 so that each pump100 can be used with one medicine cartridge 120. In these examples, theuser can obtain from the pharmacy 60 the two pump devices 100, the twomedicine cartridges 120, and the four infusion sets 146 in a singletransaction 65. This transaction 65 can be accomplished with a singlecopay payment 58 in some circumstances. In other embodiments, the numberof cartridges 120 and infusion sets 146 need not be related to thenumber of pump devices 100. The number of components provided at thetransaction 65 can be based on a number of factors, such as the type andseverity of the user's condition to be treated, the type(s) ofmedicament to be delivered, the style of infusion sets 146 to be used,and the like.

Still referring to FIG. 1, in some embodiments the user 52 can refillthe prescription 54 at the pharmacy 60 over a period of time. When theprescription 54 is written, the medical professional can indicate on theprescription 54 a maximum number of times (e.g., five, ten, twelve, orthe like) that the prescription 54 can be refilled or the maximumduration of time in which refills can be obtained. Accordingly, the user52 can initiate a refill transaction 69 in which the user 52 indicatesthe prescription 54 to be refilled and provides a refill copay payment59. In response, the user 52 can receive from the pharmacist 62 acontainer 79 (e.g., a bag) containing one or more components listed onthe prescription 54. In cases where the prescription is refillable, thepharmacy 60 can maintain records containing information related to theprescription 54 and the insurance card 56 in anticipation of futurevisits by the customer 52. Thus, the customer 52 can supply thepharmacist 62 with the refill copay payment 59, but may not be requiredto provide a new written prescription or the insurance card 56 in orderto receive the container 79. The pharmacy 60 can keep track of how manytimes the prescription 54 is refilled and may stop refilling theprescription 54 once the number of refills or refill time period exceedsthe maximum allowed. Thereafter, the customer 52 can contact a medicalprofessional to obtain a new prescription.

After each transaction 65 or refill transaction 69, the user 52 canemploy the infusion pump(s) 100 to infuse the medicine in thecartridge(s) 120 through the infusion sets 146. In this embodiment, theinfusion pump device 100 comprises a disposable one-time-use pump thatis part of a portable system 10 (described in more detail below). Inparticular, each pump device 100 can be attached with a reusablecontroller device 200 (described in more detail below) to activate thepump drive system in the infusion pump device 100.

In some embodiments, the individual that presents the prescription 54,insurance card 56, and the copay 58 is also the pump user of theassembled infusion pump system 10. It should be understood from thedescription herein that the pump user can provide the information andcomplete the transactions 65 and 69 using an agent or proxy (e.g.,friends, family members, and the like). Additionally, although FIG. 1depicts the user 52 as going to a pharmacy building, it should beunderstood that the pharmacy 60 may comprise a direct order system. Inone example, a user 52 could submit (via phone or Internet) theinformation listed on the prescription 54 and the insurance card 56 to aservice operator, along with an electronic copay 58 (e.g., credit card,e-check, or the like). After supplying the information in this manner,the user 52 can then choose to travel to a pharmacy building or elect tohave the components shipped directly to the user's address (e.g., athome, at work, or the like).

Referring now to FIGS. 2-3, some embodiments of the infusion pump system10 can include a disposable pump device 100 and a reusable controllerdevice 200 that can communicate with the pump device 100. The pumpdevice 100 can include a housing structure 110 that defines a cavity 116in which the fluid cartridge 120 can be received. The pump device 100also can include a cap device 130 to retain the fluid cartridge 120 inthe cavity 116 of the housing structure 110. The pump device 100 caninclude a drive system (described in more detail below) that advances aplunger 125 in the fluid cartridge 120 so as to dispense fluidtherefrom. The controller device 200 can communicate with the pumpdevice 100 to control the operation of the pump's drive system. When thecontroller device 200, the pump device 100 (including the cap device130), and the fluid cartridge 120 are assembled together, the user can(in some embodiments) conveniently wear the infusion pump system 10 onthe user's skin under clothing or in the user's pocket while receivingthe fluid dispensed from the pump device 100.

The controller device 200 may be configured as a reusable component thatprovides electronics and a user interface to control the operation ofthe pump device 100. In such circumstances, the pump device 100 can be adisposable and non-reusable component that is discarded after a singleuse. For example, as described in more detail below in connection withFIGS. 6-11, the pump device 100 can be a “one time use” component thatis thrown away after the fluid cartridge 120 therein is exhausted.Thereafter, the user can removably attach a new pump device 100′ (havinga new medicine cartridge 120′ as shown in FIG. 8) to the reusablecontroller device 200 for the dispensation of fluid from the new fluidcartridge 120′. Accordingly, the user is permitted to reuse thecontroller device 200 (which may include valuable electronics or data)while disposing of the relatively low-cost pump device 100 after eachuse. Such a pump system 10 can provide enhanced user safety as a newpump device 100 (and drive system therein) is employed with each newfluid cartridge 120. Moreover, such a pump system 10 can provide theuser with an opportunity to obtain a plurality of the pump devices 100at the pharmacy 60 (FIG. 1) while also obtaining the prescribed medicine(e.g., in the cartridges 120).

Briefly, in use, the pump device 100 can be configured to be removablyattached to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connectionthat is resistant to water migration. For example, as described in moredetail below in connection with FIGS. 6-11, the controller device 200can include a housing 210 having a number of features that mate withcomplementary features of the pump housing 110. In such circumstances,the controller device 200 can be removably attached to the pump device100 in a generally side-by-side configuration while not fullysurrounding the pump housing 110. Accordingly, in this embodiment, thepump device 100 and the controller device 200 can be separate componentsthat fit together in a compact manner. The compact size permits theinfusion pump system 10 to be discrete and portable (as described belowin connection with FIGS. 4-5). Moreover, at least one of the pump device100 or the controller device 200 can include a release member thatfacilitates an easy-to-use detachment and replacement process.

Still referring to FIGS. 2-3, the pump system 10 can be a medicalinfusion pump system that is configured to controllably dispense amedicine 126 (FIG. 2) from the cartridge 120. As such, the fluidcartridge 120 can contain the medicine 126 to be infused into the tissueor vasculature of a targeted individual, such as a human or animalpatient. For example, the pump device 100 can be adapted to receive amedicine cartridge 120 in the form of a carpule that is preloaded withinsulin or another medicine for use in the treatment of Diabetes (e.g.,Byetta®, Symlin®, or others). Such a cartridge 120 may be supplied, forexample, by Eli Lilly and Co. of Indianapolis, Ind. Other examples ofmedicines contained in the fluid cartridge 120 include: pain reliefdrugs, hormone therapy, blood pressure treatments, anti-emetics,osteoporosis treatments, or other injectable medicines. The fluidcartridge 120 may have other configurations. For example, the fluidcartridge may comprise a reservoir that is integral with the pumphousing structure 110 (e.g., the fluid cartridge can be defined by oneor more walls of the pump housing structure 110 that surround a plungerto define a reservoir in which the medicine is injected or otherwisereceived). In those circumstances, the user may receive vials of themedicine from the pharmacy 60 (FIG. 1) in order to fill the reservoir,or the pump devices 100 may be prefilled with the medicine before theuser obtains the pump devices 100.

In some embodiments, the pump device 100 can include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 2, the pump housing structure 110 can includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. For example, after themedicine cartridge 120 is inserted to a particular depth, the retainerwings 119 are biased to flex outward (toward the center of the cavity116) so that the retainer wings 119 engage a neck portion 129 of themedicine cartridge 120. Such a configuration may facilitate the“one-time-use” feature of the pump device 100. In some embodiments, theretainer wings 119 interfere with attempts to remove the medicinecartridge 120 from the pump device 100, thus ensuring that the pumpdevice 100 will be discarded along with the medicine cartridge 120 afterthe medicine cartridge 120 is emptied, expired, or otherwise exhausted.Accordingly, the pump device 100 can operate in a tamper-resistant andsafe manner because the pump device 100 can be designed withpredetermined life expectancy (e.g., the “one-time-use” feature in whichthe pump device is discarded after the medicine cartridge 120 isemptied, expired, or otherwise exhausted).

Still referring to FIGS. 2-3, the controller device 200 can be removablyattached to the pump device 100 so that the two components aremechanically mounted to one another in a fixed relationship. Such amechanical mounting can form an electrical connection between theremovable controller device 200 and the pump device 100. For example,the controller device 200 can be in electrical communication with aportion of a drive system 300 (not shown in FIGS. 1-3, refer to FIG. 13)of the pump device 100. As described in more detail below, the pumpdevice 100 can include a drive system that causes controlleddispensation of the medicine or other fluid from the cartridge 120. Insome embodiments, the drive system incrementally advances a piston rod(not shown in FIGS. 2-3) longitudinally into the cartridge 120 so thatthe fluid is forced out of an output end 122. A septum 121 (FIG. 2) atthe output end 122 of the fluid cartridge 120 can be pierced to permitfluid outflow when the cap device 130 is connected to the pump housingstructure 110 (described in more detail below). Thus, when the pumpdevice 100 and the controller device 200 are attached and therebyelectrically connected, the controller device 200 can communicateelectronic control signals via a hardwire-connection (e.g., electricalcontacts or the like) to the drive system or other components of thepump device 100. In response to the electrical control signals from thecontroller device 200, the drive system of the pump device 100 causesmedicine to incrementally dispense from the medicine cartridge 120.

As shown in FIG. 2, the pump device 100 can include an electricalconnector 118 (e.g., having conductive pads, pins, and the like) thatare exposed to the controller device 200 and that mate with acomplementary electrical connector (refer to connector 218 in FIG. 7) onthe adjacent face of the controller device 200. The electricalconnectors 118 and 218 provide the electrical communication between thecontrol circuitry (refer, for example, to FIG. 12) housed in thecontroller device 200 and at least a portion of the drive system orother components of the pump device 100. For example, in someembodiments, the electrical connectors 118 and 218 can permit thetransmission of electrical control signals to the pump device 100 andthe reception of feedback signals (e.g., sensor signals) from particularcomponents within the pump device 100. Furthermore, the infusion pumpsystem 10 can include a gasket 140 that provides a seal around theelectrical connector interface to thereby resist migration of externalcontaminants when the pump device 100 is attached to the controllerdevice 200. Thus, in some embodiments, the infusion pump system 10 canbe assembled into a water resistant configuration that protects theelectrical interconnection from water migration (e.g., if the userencounters water while carrying the pump system 10).

In some embodiments, the pump device 100 may be moved in a longitudinaldirection toward the controller device 200 until one or more structuresconnect and secure the separate components in the side-by-sidearrangement. For example, the controller device 200 includes acontroller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection. In theembodiment shown in FIG. 2, the pump housing structure 110 includes abarrel 111 that mates with a complementary barrel channel 211 of thecontroller housing 210. Also, the pump housing 110 includes sliderchannel 112 that slidably engages a complementary rail 212 defined bythe controller housing 210. The slider channel 112 can guide therelative motion between the pump device 100 and the controller device200 in the longitudinal direction during the attachment process.Similarly, the pump housing 110 may include a segmented rail 114 a-bthat mates with a guide channel 214 a-b (FIG. 7) to direct the relativelongitudinal motion between the pump device 100 and the controllerdevice 200. As described in more detail below, the segmented rails 114a-b may interact with a release member 215 (FIG. 7) so as to releasablysecure the pump device 100 into assembly with the controller device 200.In addition, the pump housing 110 may include an extension 113 thatmates with a depression 213 (FIG. 7) in the controller housing 210 whenthe pump device 100 is fully attached to the controller device 200.

Still referring to FIG. 2, when the pump device 100 is advanced in thelongitudinal direction toward the controller device 200 as guided by theslider channel 112 and the segmented rails 114 a-b, the electricalconnector 118 of the pump device 100 is directed toward engagement withthe mating connector 218 (FIG. 7) of the controller device 200. As theconnectors 118 and 218 join together to form the electrical connection,the release member 215 (FIG. 7) is shifted to a position between thesegmented rails 114 a-b so as to prevent withdrawal of the connection.Also, when the connectors 118 and 218 are mated, the extension 113 andbarrel 111 are mated with the corresponding depression 213 (FIG. 7) andbarrel channel 211 so as to resist relative rotational movement betweenthe pump device 100 and the controller device 200. In this embodiment,the physical attachment of the electrical connectors 118 and 218 mayalso serve to resist relative rotational movement between the pumpdevice 100 and the controller device 200. Furthermore, when theconnectors 118 and 218 are mated, the slide channel 112 is mated withthe corresponding rail 212 and barrel channel 211 so as to resistrelative side-to-side movement between the pump device 100 and thecontroller device 200.

Also, when the connectors 118 and 218 join together to form theelectrical connection, the gasket 140 is compressed between the adjacentsurfaces of the pump housing 110 and the controller housing 210. Thegasket 140 may comprise a polymer foam material that is adhered to asurface of either the pump housing 110 or the controller housing 210(e.g., adhered to the pump housing 110 in this embodiment). The gasket140 may be die cut to a selected shape so as to include an aperture forthe electrical connection. Thus, in this embodiment, the gasket 140surrounds the electrical connection when the pump device 100 is securedto the controller device 200. The configuration provides protection fromwater migration to one or both of the electrical connectors 118 and 218.Accordingly, in particular circumstances, the infusion pump system 10can be assembled into a “water tight” configuration that protectssensitive internal components from water migration in the event that theuser encounters water while wearing the pump system 10.

Additionally, in some embodiments, the attachment of the pump device 100to the controller device 200 can be accomplished by a user with aconvenient “one-movement” process. For example, as previously described,the user can readily slide the pump device 100 and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. As described in more detail below in connection with FIGS.6-11, the release member 215 may be arranged so as to automaticallyadjust to a locked position when the pump device 100 is advanced intoengagement with the controller device 200. Thus, the infusion pumpsystem 10 permits users to readily join the pump device 100 and thecontroller device 200 without compound or otherwise difficult handmovements—a feature that can be beneficial to child users or to elderlyusers.

It should be understood that, in other embodiments, other features orconnector devices can be used to facilitate the side-by-side mountingarrangement. These other features or connector devices may include, forexample, magnetic attachment device, mating tongues and grooves,mounting protrusions that friction fit into mating cavities, or thelike.

Still referring to FIGS. 2-3, the controller device 200 can include auser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 includes adisplay device 222 and one or more user-selectable buttons (e.g., fourbuttons 224 a, 224 b, 224 c, and 224 d in this embodiment). The displaydevice 222 can include an active area in which numerals, text, symbols,images, or a combination thereof can be displayed (refer, for example,to FIG. 2), which can be used to communicate a number of settings ormenu options for the infusion pump system 10. For example, the displaydevice 222 can be used to communicate medicinal delivery information227, such as the basal delivery rate, a bolus dosage, a historicalrecord of medicine delivered, the amount of medicine remaining in thecartridge 120, or the like. In another example, the display device 222can be used to communicate time and date information 228, which can beused by the user to determine dosage schedules, bolus delivery times,meal times, or the like.

In this embodiment, the user may press one or more of the buttons 224 a,224 b, 224 c, and 224 d to shuffle through a number of menus or programscreens that show particular settings and data (e.g., review data thatshows the medicine dispensing rate, the total amount of medicinedispensed in a given time period, the amount of medicine scheduled to bedispensed at a particular time or date, the approximate amount ofmedicine remaining in the cartridge 120, or the like). In someembodiments, the user can adjust the settings or otherwise program thecontroller device 200 by pressing one or more buttons 224 a, 224 b, 224c, and 224 d of the user interface 220. For example, in embodiments ofthe infusion pump system 10 configured to dispense insulin, the user maypress one or more of the buttons 224 a, 224 b, 224 c, and 224 d tochange the dispensation rate of insulin or to request that a bolus ofinsulin be dispensed immediately or at a scheduled, later time.Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user can be provided with the opportunity to readilymonitor infusion pump operation by simply viewing the user interface 220of the controller device 200 connected to the pump device 100. Suchmonitoring capabilities may provide comfort to a user who may haveurgent questions about the current operation of the pump device 100.Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200, which is removably attachedto the pump device 100, without the requirement of locating andoperating a separate monitoring module.

Referring to now FIGS. 3-5, the infusion pump system 10 may beconfigured to be portable so that the user can readily carry or wear thepump system during operation. For example, a user can conveniently wearthe infusion pump system 10 on the user's skin (e.g., skin adhesive)underneath the user's clothing or carry the pump device 100 in theuser's pocket (or other portable location) while receiving the medicinedispensed from the pump device 100. As described below in connectionwith FIG. 13, the drive system of the pump device 100 may be arranged ina compact manner so that the pump device 100 has a reduced length. Forexample, in the circumstances in which the medicine cartridge 120 has alength of about 6 cm to about 7 cm (about 6.4 cm in one embodiment), theoverall length of the pump housing structure 110 (which containsmedicine cartridge and the drive system) can be about 7 cm to about 10cm and about 7 cm to about 9 cm (about 8.3 cm or less in oneembodiment). In addition, the pump housing structure 110 may have anoverall height of about 2 cm to about 4 cm (about 3.1 cm or less in oneembodiment) and an overall thickness of about 8 mm to about 20 mm (about17.5 mm or less in one embodiment). In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump system 10 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 7 cm to about 10 cm (about 9.3cm or less in one embodiment), an overall height of about 2 cm to about5 cm (about 4.2 cm or less in one embodiment), and an overall thicknessof about 8 mm to about 20 mm (about 17.5 mm or less in one embodiment).

The pump system 10 is shown in FIG. 3 as being held in a user's hand 5so as to illustrate an exemplary size of the system 10 in accordancewith some embodiments. This embodiment of the infusion pump system 10 iscompact so that the user can wear the portable infusion pump system 10(e.g., in the user's pocket, connected to a belt clip, adhered to theuser's skin, or the like). In such embodiments, the pump device 100 candeliver the medicine 126 through the infusion set 146.

As shown in FIG. 3, the infusion set 146 includes a tubing system thatconnects the infusion pump system 10 to the tissue or vasculature of theuser (e.g., to deliver medicine into the tissue or vasculature under theuser's skin). The infusion set 146 may include a flexible tube 147 thatextends from the pump device 100 to a subcutaneous cannula 149 retainedby a skin adhesive patch 148 that secures the subcutaneous cannula 149to the infusion site. The skin adhesive patch 148 can retain theinfusion cannula 149 in fluid communication with the tissue orvasculature of the patient so that the medicine dispensed through thetube 147 passes through the cannula 149 and into the user's body. Thecap device 130 may provide fluid communication between the output end122 (FIG. 2) of the medicine cartridge 120 and the tube 147 of theinfusion set 146. For example, the tube 147 may be directly connected toan output port 139 (FIG. 2) of the cap device 130. In another example,the infusion set 146 may include a connector (e.g., a Luer connector orthe like) attached to the tube 147, and the connector can then mate withthe cap device 130 to provide the fluid communication to the tube 147.In these examples, the user can carry the portable infusion pump system10 (e.g., in the user's pocket, connected to a belt clip, adhered to theuser's skin, or the like) while the tube 147 extends to the location inwhich the skin is penetrated for infusion. If the user desires tomonitor the operation of the pump device 100 or to adjust the settingsof the infusion pump system 10, the user can readily access the userinterface 220 of the controller device 200 without the need for carryingand operating a separate module

In the event that an alarm condition (e.g., low power, low medicinevolume, occlusion detection, drive system or electrical communicationerror, or the like) is detected by the pump system 10, the displaydevice 222 can be used to communicate an alert to the user. If the pumpsystem 10 detects an occlusion in the medicine flow path (which cancause inaccurate dosage delivery), an audible alert, in addition to orin place of the alert displayed on the device 222, can be used to notifythe user of the detected occlusion. The audible alert may be in the formof an alert beep, a voice notification, or a combination thereof. Inparticular embodiments, the audible alert can include a voicenotification that states: “Alert. An occlusion has been detected. Pleasecheck the infusion set for blockages.” In addition, the display device222 may provide a visual alert that indicates the detected alarmcondition. In some examples, the user can acknowledge the alarmcommunication by pressing the button 224 b adjacent to a “clear”command. Other alarm conditions may require further intervention by theuser. In those situations, the audible alert may include voiceinstructions that indicate the actions to be performed by the user.

Referring to FIG. 4-5, a user can conveniently wear the infusion pumpsystem 10 on the user's skin (e.g., through the use of skin adhesive)underneath the user's clothing or carry the pump device 100 in theuser's pocket (or other portable location) while receiving the medicinedispensed from the pump device 100. As shown in FIG. 4, in someembodiments, the infusion pump system 10 is pocket-sized so that thepump device 100 and controller device 200 can be worn in a user's pocket6 or in another portion of the user's clothing. For example, the pumpdevice 100 and the controller device 200 can be attached together andform the system 10 that comfortably fits into a user's pocket 6. Theuser can carry the portable infusion pump system 10 and use the tube 147of the infusion set 146 to direct the dispensed medicine to the desiredinfusion site. In some circumstances, the user may desire to wear thepump system 10 in a more discrete manner. Accordingly, the user may passthe tube 147 from the pocket 6, under the user's clothing, and to theinfusion site where the adhesive patch 148 is positioned. As such, thepump system 10 can be used to delivery medicine to the tissues orvasculature of the user in a portable, concealable, and discrete manner.

Referring to FIG. 5, in other embodiments, the infusion pump system 10may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface (not shown) of the pump device 100 may include askin adhesive patch so that the pump device 100 is physically adhered tothe skin of the user at a particular location. In these embodiments, thecap device 130 (FIG. 2) may have a configuration in which medicinepasses directly from the cap device 130 into an infusion cannula 149that is penetrated into the user's skin. In one example, the fluidoutput port 139 (FIG. 2) through the cap device 130 can include a curveor a 90° corner so that the medicine flow path extends longitudinallyout of the medicine cartridge and thereafter laterally toward thepatient's skin 7. Again, if the user desires to monitor the operation ofthe pump device 100 or to adjust the settings of the infusion pumpsystem 10, the user can readily access the user interface 220 of thecontroller device 200 without the need for carrying and operating asecond, separate device. For example, the user may look toward the pumpdevice 100 to view the user interface 220 of the controller device 200that is removably attached thereto. In another example, the user cantemporarily detach the controller device 200 (while the pump device 100remains adhered to the skin 7) so as to view and interact with the userinterface 220.

Referring now to FIGS. 6-11, the infusion pump system 10 can be operatedsuch that the pump device 100 is a disposable, non-reusable componentwhile the controller device 200 is a reusable component. In thesecircumstances, the pump device 100 may be configured as a “one-time-use”device that is discarded after the medicine cartridge 120 is emptied,expired, or otherwise exhausted. Thus, in some embodiments, the pumpdevice 100 may be designed to have an expected operational life of about1 day to about 30 days, about 1 day to about 20 days, about 1 to about14 days, or about 1 day to about 7 days—depending on the volume ofmedicine in the cartridge 120, the dispensation patterns that areselected for the individual user, and other factors. For example, insome embodiments, the medicine cartridge 120 containing insulin may havean expected usage life about 7 days after the cartridge 120 is removedfrom a refrigerated state and the septum 121 is punctured. In somecircumstances, the dispensation pattern selected by the user can causethe insulin to be emptied from the medicine cartridge 120 before the7-day period. If the insulin is not emptied from the medicine cartridge120 after the 7-day period, the remaining insulin may become expiredsometime thereafter. In either case, the pump device 100 and themedicine cartridge 120 therein can be discarded after exhaustion of themedicine cartridge 120 (e.g., after being emptied, expired, or otherwisenot available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120′. Furthermore, the pumpsystem 10 can provide the user with an opportunity to obtain a pluralityof the pump devices 100 at the pharmacy 60 (FIG. 1) over a period oftime.

Referring to FIGS. 6-7, the pump device 100 can be readily removed fromthe controller device 200 when the medicine cartridge 120 is exhausted.As previously described, the medicine cartridge 120 is inserted into thecavity 116 (FIG. 2) of the pump housing 110 where it is retained by thecap device 130. In some embodiments, a portion of the pump housing 110can comprise a transparent or translucent material so that at least aportion of the medicine cartridge 120 is viewable therethrough. Forexample, the user may want to visually inspect the medicine cartridgewhen the plunger 125 is approaching the output end 122 of the medicinecartridge, thereby providing a visual indication that the medicinecartridge may be emptied in the near future. In this embodiment, thebarrel 111 of the pump housing 110 comprises a generally transparentpolymer material so that the user can view the medicine cartridge 120 todetermine if the plunger 125 is nearing the end of its travel length.Optionally, some embodiments of the pump device 100 may include a label117 a that is adhered around the barrel 111. The label 117 a may providea convenient location for basic user instructions, productidentification information, and other information related to theinfusion pump system 10. To provide enhanced viewability of the medicinecartridge 120 through the label 117 a, the label 117 a may include awindow 117 b through which the user may visually inspect if the plunger125 is nearing the end of its travel length.

As shown in FIG. 6, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 6, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 (and through the window 117 b of the label117 a in this embodiment) to determine if the medicine cartridge 120 isalmost empty. When the user determines that a new medicine cartridge 120should be employed, the pump device 100 can be readily separated fromthe controller device 200 by actuating the release member 215. In thisembodiment, the release member 215 is a latch on the controller device200 that is biased toward a locking position to engage the pump device100. The latch 215 may be arranged to engage one or more features on alateral side of the pump housing 110. As such, the user may actuate therelease member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 6) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 7, when the release member 215 is actuated and moved toa position away from the pump device 100, the segmented guide rail 114a-b is free to slide longitudinally in the guide channel 214 a-b withoutinterference from the release member 215. Accordingly, the user can movethe pump device 100 in a longitudinal direction 217 away from thecontroller device 200. For example, the segmented guide rail 114 a-b mayslide along the guide channel 214 a-b, the extension 113 (FIG. 2) may bewithdrawn from the mating depression 213, and the electrical connector118 can be separated from the mating connector 218. In thesecircumstances, the pump device 100 is physically and electricallydisconnected from the controller device 200 while the pump deviceretains the exhausted medicine cartridge 120.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., move in the lateral direction 216 in theembodiment shown in FIG. 6). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 8-9, the same controller device 200 can be reusedwith the new pump device 100′ having the new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. As previouslydescribed in connection with FIG. 1, the user may obtain a plurality ofthe pump devices 100 from a single pharmacy transaction, so the new pumpdevice 100′ may be readily available to the user after exhaustion of theprevious pump device 100. The new pump device 100′ (FIG. 8) can have asimilar appearance, form factor, and operation as the previously usedpump device 100 (FIGS. 6-7 and 9), and thus the new pump device 100′ canbe readily attached to the controller device 200 for controlleddispensation of medicine from the new medicine cartridge 120′. In someembodiments, the user may prepare the new pump device 100 for use withthe controller device 200. For example, the user may insert the newmedicine cartridge 120′ in the cavity 116 of the new pump device 100′and then join the cap device 130 to the pump housing to retain the newmedicine cartridge 120′ therein (refer, for example, to FIG. 2).Although the tubing 147 of the infusion set 146 is not shown in FIG. 8,it should be understood that the tubing 147 may be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 146 can be connected to the capdevice 130 so that the tubing 147 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller 200) beforeattaching the infusion set patch to the user's skin. As shown in FIG. 8,the new medicine cartridge 120′ may be filled with medicine such thatthe plunger 125 is not viewable through the barrel 111.

As shown in FIG. 9, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 6-7) may be discarded after a single use. In these circumstances,the pump device 100 may be configured as a disposable “one-time-use”device that is discarded by the user after the medicine cartridge 120 isemptied, is expired, has ended its useful life, or is otherwiseexhausted. For example, the pump device 100 may be discarded into a bin20, which may include a trash bin or a bin specifically designated fordiscarded medical products. Thus, the user is permitted to dispose ofthe relatively low-cost pump device 100 after each use while reusing thecontroller device 200 (which may include complex or valuableelectronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 146 (not shown in FIG. 9, refer to FIG.3) that was used with the pump device 100 may be removed from the userand discarded into the bin 20 along with the pump device 100.Alternatively, the infusion set 146 can be disconnected from theprevious pump device 100 and attached to the new pump device 100′. Inthese circumstances, the user may detach the infusion set cannula andpatch from the skin so as to “re-prime” the tubing with medicine fromthe new pump device 100′ to remove air pockets from the tubing.Thereafter, the infusion set cannula and patch can be again secured tothe user's skin.

Referring to FIGS. 10-11, the new pump device 100′ can be removablyattached to the controller device 200 to assemble into the infusion pumpsystem 10 for delivery of medicine to the user. Before the pump device100 is electrically connected with the controller device 200, the usermay prepare the new pump device 100′ for use by pulling a removable tab141 away from the pump housing 110. In this embodiment, the new pumpdevice 100′ includes the removable tab 141 to seal the battery in theunused pump device 100′ and thereby maintain the battery in a storagemode (refer, for example, to FIG. 14 in which the removable tab 141 isarranged to cover an internal face of a vent 145). The vent 145 can beimplemented in some embodiments of the infusion pump system 10 having apower source arranged that draws upon surrounding air for optimumoperation. Because the controller device 200 and the pump device 100 maybe sealed to resist water migration during normal usage, thewater-resistant vent instrument 145 may be used to provide the air tothe power source without permitting migration of water therethrough. Forexample, in this embodiment, the pump device 100 may house a powersource 345 in the form of a zinc-air cell battery (refer to FIG. 13),which draws upon the surrounding air during operation. When the pumpdevice 100 is in use, the pump housing 110 is preferably sealed toprotect the internal drive system and medicine cartridge from watermigration. As such, the pump housing 110 may include the water-resistantvent 145 disposed proximate to the zinc-air cell battery 345 so thatsome air may pass through the vent 145 and toward the battery. Thewater-resistant vent instrument 145 may include one or more layers of amaterial that is permeable to air and resistant to passage of liquidssuch as water. For example, the water-resistant vent instrument 145 mayinclude one or more layers of a GORE-TEX material to resist themigration of water into the pump device while permitting the passage ofair toward the battery.

As described in more detail below, when the new pump device 100′ isprepared for usage, the removable tab 141 can be pulled away from thepump housing 110 (and away from the battery therein), which switches thebattery into an activation mode. Thus, the shelf-life of the pump device100′ (prior to usage with the controller device 200) may be extended bysealing the battery in a storage mode because little, if any, energy isdissipated from the battery when in the storage mode.

The new pump device 100′ can be connected to the controller device 200by advancing the new pump device 100′ in a longitudinal direction 219(FIG. 10) toward the controller device 200. When the pump device 100′ isadvanced in the longitudinal direction 219 toward the controller device200, the movement is guided by the slider channel 112 (FIG. 2) and thesegmented rails 114 a-b. In particular, the slider channel 112 of thepump housing engages the rail 212 of the controller housing 210. Also,the front portion of the segmented rail 114 a slides into the rearportion of the guide channel 214 b. In this embodiment, the frontportion of the segmented rail 114 a includes a ramp surface 114 c (referalso to FIG. 2) that engages a complementary ramp surface of the releasemember 215 to thereby force the release member 215 away from the guidechannel 214 a-b during advancement of the pump device 100′. The releasemember 215 is temporarily forced away from the guide channel 214 a-b sothat the front portion of the segmented rail 114 a passes over therelease member 215, which enables the electrical connector 118 of thepump device 100′ to engage with the mating connector 218 of thecontroller device 200. As the connectors 118 and 218 join together toform the electrical connection, the release member 215 biased to returnto its latched position and is shifted to a position in the guidechannel 214 a-b between the segmented rails 114 a-b so as to preventwithdrawal of the pump device 100′.

As previously described, the guided motion in the longitudinal direction219 provides the user with a convenient “one-movement” process to attachthe pump device 100′ and the controller device 200. For example, theuser can readily slide the pump device 100′ and the controller device200 toward one another in a single movement (e.g., in the longitudinaldirection) that causes both a physical connection and an electricalconnection. Thus, the infusion pump system 10 permits users to readilyjoin the pump device 100′ and the controller device 200 without compoundor otherwise difficult hand movements—a feature that can be beneficialto child users or to elderly users.

As shown in FIG. 11, when the new pump device 100′ is fully advanced andattached to the controller device 200, the gasket 140 is compressedbetween the opposing surfaces of the pump housing 110 and the controllerhousing 210. Such a configuration provides a water-resistance sealaround the electrical connection that protects the sensitive internalcomponents of the pump device 100′ and the controller device 200 fromdamage or malfunction. As previously described in connection with FIG.3, the tubing 147 of the infusion set 146 can be attached to the capdevice 130 to provide a fluid path from the new pump device 100′ to theuser. Thus, the new pump device 100′ can deliver medicine to the userunder the control of the reusable controller device 200.

Referring now to FIG. 12, the controller device 200 (shown in anexploded view) houses a number of components that can be reused with aseries of successive pump devices 100. In particular, the controllerdevice 200 includes control circuitry 240 arranged in the controllerhousing 210 that is configured to communicate control signals to thedrive system of the pump device 100. In this embodiment, the controlcircuitry 240 includes a main processor board 242 that is incommunication with a power supply board 244. The control circuitry 240includes at least one processor 243 that coordinates the electricalcommunication to and from the controller device 200 (e.g., communicationbetween the controller device 200 and the pump device 100). Theprocessor 243 can be arranged on the main processor board 242 along witha number of other electrical components such as at least one memorydevice 246. It should be understood that, although the main processorboard 242 is depicted as a printed circuit board, the main processorboard can have other forms, including multiple boards, a flexiblecircuit substrate, and other configurations that permit the processor243 to operate. The control circuitry 240 can be programmable in thatthe user may provide one or more instructions to adjust a number ofsettings for the operation of the infusion pump system 10. Such settingsmay be stored in the memory device 246 arranged in the control circuitry240. Furthermore, in some embodiments the memory device 246 can storeexecutable software instructions for the processor 243. Alternatively,the control circuitry 240 may include other dedicated memory devices(e.g., separate from the memory device 246) that store executablesoftware instructions for the processor 243. The control circuitry 240may include other components, such as sensors, that are electricallyconnected to the main processor board 242. For example, at least aportion of an occlusion sensor system (not shown in FIG. 12) can beelectrically connected to the main processor board 242 via a flexiblecircuit substrate or one or more wires.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218(FIGS. 2 and 7) so that the control circuitry 240 can communicatecontrol signals to the pump device 100 and receive feedback signals fromcomponents housed in the pump device 100. In this embodiment, theelectrical connector 118 (FIG. 2) on the pump device 100 is a z-axisconnector, and the connector 218 (FIG. 7) on the controller device 200is adapted to mate therewith. The electrical connector 218 on thecontroller device 200 is in communication with the control circuitry240. As such, the processor 243 can operate according to softwareinstructions stored in the memory device 246 so as to send controlsignals to the pump device 100 via the connector 218.

The memory device 246 may store infusion pump data, such as pumpsettings and menu options, basal and bolus dispensation data, executablesoftware instructions (for the processor 243) that control the operationof the pump device 100, and the like. The memory device 246 can beselected to provide ample storage space for the infusion pump data sothat the pump device 100 can safely dispense the medicine in accordancewith the signals from the properly operating control device 200. Inparticular embodiments, the memory device 246 may have a portion that ispartitioned or segregated from the other contents of the memory device246 or otherwise protected from overwriting during the process ofupdating or changing the content in other portions of the memory device246. In alternative embodiments, the memory device 246 may comprise aplurality of separate memory cards or memory chips accessible to theprocessor 243, some of which are dedicated to the infusion pump data.

Still referring to FIG. 12, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes the display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of settings or menu options for theinfusion pump system 10. In this embodiment, the control circuitry 240may receive the input commands from the user's button selections andthereby cause the display device 222 to output a number of menus orprogram screens that show particular settings and data (e.g., reviewdata that shows the medicine dispensing rate, the total amount ofmedicine dispensed in a given time period, the amount of medicinescheduled to be dispensed at a particular time or date, the approximateamount of medicine remaining the cartridge 120, or the like). Aspreviously described, the controller circuit 240 can be programmable inthat the input commands from the button selections can cause thecontroller circuit 240 to change any one of a number of settings for theinfusion pump system 10. Some embodiments of the pump system 10 includea cable connector (e.g., a data cable port or a data cable that mateswith connector 218) for communicating with a separate computer system.As such, the data cable may electrically connect to the controlcircuitry 240 to upload data or program settings to the controlcircuitry 240 or to download data from the control circuitry 240. Forexample, historical data of medicine delivery can be downloaded from thecontrol circuitry 240 (via the cable connector) to a computer system ofa physician or a user for purposes of analysis and program adjustments.Optionally, the data cable may also provide recharging power.

Still referring to FIG. 12, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 that can receiveelectrical energy from a first power source 345 (FIG. 13) housed in thepump device 100. In this embodiment, the second power source 245 iscoupled to the power supply board 244 of the control circuitry 240. Thehard-wired transmission of the electrical energy can occur through thepreviously described connectors 118 and 218 (FIGS. 2 and 7). In suchcircumstances, the first power source 345 (FIG. 13) may include a highdensity battery that is capable of providing a relatively large amountof electrical energy for its package size, while the second power source245 (FIG. 12) may include a high current-output battery that is capabledischarging a brief current burst to power a drive system 300 of thepump device 100. Accordingly, the first battery 345 disposed in the pumpdevice 100 can be used to deliver electrical energy over time (e.g.,“trickle charge”) to the second battery 245 when the controller device200 is removably attached to the pump device 100. For example, aspreviously described, the first battery 345 may comprise a zinc-air cellbattery. The zinc-air cell battery 345 may have a large volumetricenergy density compared to some other battery types. For example, thezinc-air cell battery 345 may have a volumetric energy density ofgreater than about 900 Watt-hours/Liter (Wh/L), about 1000 Wh/L to about1700 Wh/L, and about 1200 Wh/L to about 1600 Wh/L. Also, the zinc-aircell battery may have a long storage life, especially in thoseembodiments in which the battery is sealed (e.g., by the removable tab141 or the like) during storage and before activation. One exemplaryzinc-air cell battery provides a potential voltage of about 1.1V toabout 1.6V (about 1.2V to about 1.4 V, and about 1.3 V in oneembodiment), a current output of about 8 mA to about 12 mA (about 10 mAin one embodiment), and a storage capacity of greater than about 600mA·h (about 650 mA·h in one embodiment).

As shown in FIG. 12, the second battery 245 may include a highcurrent-output device that is housed inside the controller housing 210.The second battery 245 can be charged over a period of time by the firstbattery 345 and then intermittently deliver high-current bursts to thedrive system 300 over a brief moment of time. For example, the secondbattery 245 may comprise a lithium-polymer battery. The lithium polymerbattery disposed in the controller device 200 may have an initialcurrent output that is greater than the zinc-air cell battery disposedin the pump device 100, but zinc-air cell battery may have an energydensity that is greater than the lithium polymer battery (e.g., thelithium polymer battery disposed in the controller device 200 may have avolumetric energy density of less than about 600 Wh/L). In addition, thelithium-polymer battery 245 is readily rechargeable, which permits thezinc-air battery 345 disposed in the pump device 100 to provideelectrical energy to the lithium-polymer battery 245 for purposes ofrecharging. One exemplary lithium-polymer battery provides a initialcurrent output of about greater than 80 mA (about 90 mA to about 110 mA,and about 100 mA in one embodiment) and a maximum potential voltage ofabout 4.0V to and 4.4V (about 4.2 V in one embodiment). In otherembodiments, it should be understood that the second power source 245may comprise a capacitor device capable of being recharged over time andintermittently discharging a current burst to activate the drive system300.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via awall-plug or other cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing (or possibly eliminating) theneed for separate recharging of the controller device 200 via a powercord plugged into a wall outlet.

Referring now to FIG. 13, the pump device 100 may include a drive system300 that is controlled by the removable controller device 200 (FIGS. 1-3and 8). Accordingly, the drive system 300 can accurately andincrementally dispense fluid from the pump device 100 in a controlledmanner. The drive system 300 may include a flexible piston rod 370 thatis incrementally advanced toward the medicine cartridge 120 so as todispense the medicine from the pump device 100. At least a portion ofthe drive system 300 is mounted, in this embodiment, to the pump housing110. In this embodiment, the pump housing 110 includes a chassis 107that is at least partially covered by a shell portion (removed from FIG.13 for purposes of illustrating the drive system 300). The shell portioncan be used to cover at least a portion of the drive system 300. Theshell portion can slide over and join with the chassis 107 (and otherbody portions) to form the assembled pump housing 110.

Some embodiments of the drive system 300 may include a battery poweredactuator (e.g., a reversible motor 320 or the like) that resets aratchet mechanism 330, a spring device 350 (FIG. 22) that provides thedriving force to the ratchet mechanism 330, and a drive wheel 360 thatis rotated by the ratchet mechanism 330 to advance the flexible pistonrod 370 toward the medicine cartridge 120. Also, the pump device 100 caninclude one or more motion detectors coupled with the drive system 300to provide feedback regarding the operation of the drive system 300. Forexample, the pump device 100 may include a first motion detector 302configured as a limit switch that detects when a portion of the ratchetmechanism 330 has reached the limit of its travel and must thereafterstop movement or reverse direction. In another example, the pump device100 may include a second motion detector 307 in the form of a mechanicalerror switch that indicates whether components of the drive system 300completed the desired motion for each drive cycle.

Still referring to FIG. 13, the pump device 100 includes a connectorcircuit 310 to facilitate the transfer of signals to and from theelectrical connector 118 (FIG. 1). As previously described, theelectrical connector 118 of the pump device 100 mates with the connector218 (FIG. 8) of the controller device 200 so that electricalcommunication can occur between the pump device 100 and the controllerdevice 200. The connector circuit 310 may comprise a generallynon-complex circuit 310 that does not include a processor or otherrelatively high-cost components. In this embodiment, the connectorcircuit 310 operates as a passageway for the control signals (from thecontrol circuitry 240 (FIG. 12) of the controller device 200) totransmit to the drive system 300 (e.g., to the actuator 320). Forexample, the reversible motor 320 may be connected to the connectorcircuit 310 via one or more wires 304. The connector circuit 310 alsooperates as a passageway for the electrical power from the first battery345 (FIG. 13) to pass to the controller device 200 for recharging of thesecond battery 245 (FIG. 12). For example, the first battery 345 may beconnected to the connector circuit 310 via one or more power contacts305. Furthermore, the connector circuit 310 operates as a passageway forfeedback signals (e.g., from the motion detectors 302 and 307) totransmit to the control circuitry 240 (FIG. 12) of the controller device200. For example, the limit switch 302 may be connected to the connectorcircuit 310 via one or more wires 306 (the one or more wires connectingthe mechanical error switch 307 to the connector circuit 310 are notshown in FIG. 13).

In some embodiments, the connector circuit 310 in the pump device 100includes a memory device 318 that can store data regarding the pumpdevice 100 and its operational history. For example, the memory device318 of the connector circuit 310 may include a flash memory chip that isconfigured to store data such as: a unique serial number designated forthe pump device 100, a manufacturer identifier code, and a drive cyclecounter. The unique serial number designated for the pump device 100 andthe manufacturer identifier code may be useful pieces of quality controlinformation that remains with the pump device 100 throughout itsshelf-life and operational life. If, for example, a manufacturing erroris identified for a particular pump device 100, the unique serial numberand the manufacturer identifier code (e.g., a lot code) can be used topromptly identify the manufacturing location and its manufacturing lot.

The drive cycle counter stored in the memory device 318 can be usefulfor maintaining an accurate estimate of the volume of medicine thatremains in the medicine cartridge 120. For example, the number of drivecycles that are required to incrementally advance the plunger 125 andthereby dispense a full medicine cartridge 120 may be a predeterminedvalue (e.g., in some embodiments, 6,300 drive cycles result in fulldispensation of a new medicine cartridge). Accordingly, the drive cyclecounter stored in the memory device 318 can keep track of the number ofdrive cycles that have occurred through the operational life of the pumpdevice 100. Each time the motor 320 completes a new drive cycle andincrementally advances the piston rod 370 to dispense some medicine, thecontroller device 200 can store an updated value for the drive cyclecounter stored in the memory device 318. When the updated value storedin drive cycle counter stored in the memory device 318 approaches thepredetermined value, the controller device 200 can alert the user thatthe medicine cartridge is approaching exhaustion. Furthermore, becausethe memory device 318 is arranged in the pump device 100, the drivecycle counter stored in the memory device 318 remains local to the pumpdevice 100. If the pump device 100 is temporarily disconnected from thecontroller device 200 and then reconnected (or reconnected to adifferent controller device 200), the controller device 200 can retrievethe value for the drive cycle counter stored in the memory device 318and promptly ascertain how much medicine remains in the medicinecartridge 120.

Still referring to FIG. 13, in some embodiments, the flexible piston rod370 comprises a plurality of segments 372 serially connected by hingeportions 373 so that the flexible piston rod 370 is adjustable from acurved shape to a noncurved shape. The plurality of segments 372 and theinterconnecting hinge portions 373 can be integrally formed in one piecefrom one or more moldable materials, including polymer materials such asNylon or POM. In this embodiment, each of the plurality of rod segments372 includes an exterior thread pattern 374 along at least onecylindrical surface portion. The piston rod 370 also includes a plungerengagement device 375 can be arranged at a forward end of the piston rod370. As such, the plunger engagement device 375 faces toward themedicine cartridge 120 when the medicine cartridge 120 is inserted intothe cavity 116. In some embodiments, the plunger engagement device 375may comprise a pusher disc that abuts against the plunger 125 of themedicine cartridge 120.

Because the flexible piston rod 370 is adjustable from a curved shape toa noncurved shape, the overall length of the pump device can be reducedin some embodiments. For example, in a typical infusion pump that housesa straight and rigid rod, the typical infusion pump requires a packageor housing having a linear dimension sufficient to accommodate thelength of the rigid piston rod when it is at its limit of travel inwhich it is fully withdrawn from the container or cylinder. The pumpdevice 100 incorporating the flexible piston rod 370 can require lessspace than a similar device that houses a non-flexible, rigid rod.

Accordingly, the pump device 100 is configured to removably attach tothe controller device 200 in a manner that provides a secure fitting, anoverall compact size, and a reliable electrical connection. When thepump device 100 and the controller device 200 are arranged in thisattached configuration, the controller device 200 can be electricallyconnected with the pump device 100 to control operations of the pumpdrive system 300.

Referring now to FIG. 14, some embodiments of a process 400 forobtaining an infusion pump can include a number of operations performedby a pump user. In operation 405, a patient visits a medicalprofessional, such as a doctor, regarding a medical condition (e.g.,diabetes, or another condition that can be treated through the use of aninfusion pump system). During the visit, the doctor or otherprofessional may determine that the patient is suitable for infusionpump therapy. Thereafter, in operation 410, the patient may obtain aprescription for components related to infusion pump therapy. Forexample, as previously described in connection with FIG. 1, the patientcan receive a prescription 52 that indicates the use of one or moreinfusion pumps 100 and one or more medicine cartridges 120. It should beunderstood that the prescription 52 may be in the form of instructionsto use the infusion pumps 100 even if a formal written prescription isnot necessary to obtain the pumps 100 (e.g., if the pumps are availableas over-the-counter products). The number of pump devices 100 that areprescribed in the operation 410 can be based on multiple factors, suchas severity of the condition being treated, length of time that the pumpdevice 100 is predicted to last for the patient, the length of timeexpected between visits to the pharmacy, the number of pump devices 100permitted for a single transaction by the health insurance provider, andthe like. The number of fluid cartridges 120 and infusion sets 146 thatare prescribed can depend on the number of pump devices 100 that areprescribed. For example, the number of medicine cartridges 120prescribed may be in a 1:1 ratio to the number of pump devices 100.

In some circumstances, the patient may not already possess particularcomponents of the pump system, such as the reusable controller 200 thatis not necessarily part of a refillable prescription. Optionally, inoperation 415, the patient may attend a training session regarding useof the infusion pump system. In some embodiments, this training sessiontakes place at a time prior to the patient receiving the disposablecomponents of the pump system 10. The training session can take placeusing a controller 200 used specifically for training purposes in whichcase the patient can acquire his/her own controller 200 (in operation420) after attending the training session. Alternatively, the patientmay receive his or her controller 200 for use during the trainingsession. In addition, or in the alternative, the patient can attend atraining session after acquiring all components of the pump system 10 sothat the user may not only be instructed on proper use of the pumpsystem 10, but can also configure the system 10 for use and beginreceiving treatment from the pump system 10 before leaving the trainingsession.

Returning now to portion of the process 400 after obtaining theprescription, in operation 425 the patient can submit the prescriptioninformation to a pharmacy. Optionally, in operation 430, the patientalso submits health insurance information to the pharmacy so that thepatient's health insurance will cover a portion of the costs for theinfusion pumps, medicine, or both. As previously described in connectionwith FIG. 1, the user may be required to pay only a copay payment to thepharmacy for the costs not covered by the health insurance provider. Insome cases, the entire cost of the disposable portions of the pumpsystem 10 will be covered, thus eliminating the need for the patient tosupply a copay payment in the operation 430. In some examples, theprescription, health insurance, and copay can all be provided at thesame time. In other examples, these three items can be provided at anytime and in any order. For example, the patient may be a regularcustomer of the pharmacy, thus the patient's health insuranceinformation may already be on file in the pharmacy, thus eliminating theneed for the patient to supply health insurance information during theoperation 430. In still other examples, the patient may not have healthinsurance that will cover the costs of the pump system 10, therebyeliminating the need for the patient to supply health insuranceinformation to the pharmacy. In these cases, the payment made by thepatient to the pharmacy is in place of a copay payment and representsthe entire cost of the portions of the pump system 10 received.

When the proper information and payments have been provided to thepharmacy, the patient receives from the pharmacy (in operation 435) oneor more pump devices 100. In operation 440, the patient may also receiveone or more fluid cartridges 120 from the pharmacy. In some embodiments,the number of cartridges 120 can be provided in a 1:1 ratio with thenumber of infusion pumps 100. In operation 435, the patient can receiveone or more infusion sets 146 from the pharmacy. As previously describedin connection with FIG. 1, the operations 425-445 can take place, forexample, in a brick and mortar establishment, or can take place viadirect order pharmacy system in which the information is provided fromthe patient to the pharmacy over the phone or Internet, and thecomponents of the system 10 are sent to the patient's address. Inoperation 450, the patient couples the pump device 100, fluid cartridge120, and infusion set 146 to the controller device 200 to therebyprovide controlled infusion of the medicine.

Still referring to FIG. 14, in operation 455, the patient may receive arefill quantity from the pharmacy. This may occur, for example, afterthe patient uses a quantity of the disposable components of the pumpsystem 10 (e.g., one or more pump devices 100, one or more fluidcartridges 120, and one or more infusion sets 146). In some embodiments,the prescription obtained by the patient can indicate a maximum timelimit or number of times that the prescription for the infusion pumpscan be refilled. When appropriate, the patient can contact the pharmacy,provide an additional copay payment if applicable, and receive therefill quantity of pump devices 100′, fluid cartridges 120′, and/orinfusion sets 146′ as indicated by the prescription instructions. Inoperation 460, the patient can reuse the controller device 200 with thenew infusion pump 100 and new medicine cartridges 120. For example, asdescribed in connection with FIGS. 6-11, when the pump system 10 hasexhausted the supply of medicine in the cartridge 120, the patient candiscard the disposable pump device 100 and replace it with the new pumpdevice 100′, fluid cartridge 120′, and infusion set 146′. If the numberof times that the prescription has been refilled or the refill timeperiod has equaled or exceeded the maximum amount indicated on theprescription, the patient may visit the medical professional (or anothermedical professional) for a check-up and new prescription. As such, theprocess 400 may return to operation 405 to receive a new prescriptionfor the infusion pumps and other components (e.g., medicine cartridges120) of the pump system 10.

Referring now to FIG. 15, some embodiments of a process 500 fordistributing infusion pumps can include a number of operations in apharmacy system. In operation 505, a pharmacy may order a plurality ofinfusion pump components, such as the pump devices 100, the fluidcartridges 120, and/or the infusion sets 146. In some embodiments, thepharmacy can receive these components from one or more suppliersavailable to the pharmacy. For example, the pharmacy can order the pumpdevices 100 from a single supplier, the fluid cartridges 120 from foursuppliers, and the infusion sets 146 from two different supplier.

In operation 510, the pharmacy receives the previously orderedcomponents and stores the components in its inventory. In particular,the plurality of infusion pumps 100, the plurality of medicinecartridges 120, and the plurality of infusion sets 146 can be stored inthe pharmacy inventory according to instructions supplied bymanufacturer(s) of the components. For example, the medicine cartridges120 may be stored in a refrigerated environment, while the pump devices100 and the infusion sets 146 are stored at substantially roomtemperature. In another example, the components can be received from asupplier in prepackaged kits (described below in connection with FIGS.16-17) and stored collectively in a single location. In still anotherexample, a predetermined number of the items received from the medicalsuppliers can be packaged by the pharmacy into the infusion pump kits.

Still referring to FIG. 15, in operation 515 the pharmacy may receiveprescription information from a customer regarding one or more infusionpump devices 100 and other components (e.g., medicine cartridges 120).As previously described in connection with FIG. 1, the prescriptioninformation received can instructions related to a number of pumpdevices 100, fluid cartridges 120, and (optionally) infusion sets 146that have been prescribed by a medical professional. The prescriptioninformation may also indicate the maximum refill time period or maximumnumber of times that the prescription can be refilled. The prescriptioncan be saved by the pharmacy so that in the future, the pharmacy mayprovide one or more refill quantities of the prescription without havingto require that the customer provide this information again. It shouldbe understood that, in some embodiments, the prescription informationmay include written instructions from a medical professional for the useof infusion pumps or components that do not require a formal writtenprescription. In some embodiments, the number of cartridges 120prescribed in the prescription information may be in a 1:1 ratio withthe number of pump devices 100.

In operation 520, the pharmacy may optionally receive health insuranceinformation (e.g., an insurance card or the like) from the customer. Thehealth insurance information can provide information about thecustomer's health care coverage (e.g., contact information for thehealth insurance provider, a customer identifier, and the like), whichcan be saved by the pharmacy for future use when the customer returnsfor a refill quantity of the prescription. In operation 525, thepharmacy may receive a copay payment from the customer to cover thecosts of the components in the prescription that are not covered by thehealth insurance provider. It should be understood from the descriptionherein that the prescription, health insurance information, and copaycan be received by the pharmacy contemporaneously or at different pointsin time.

Still referring to FIG. 15, in operation 530, the pharmacy provides tothe customer one or more infusion pumps. As previously described inconnection with FIG. 1, the infusion pumps may include disposable pumpdevices 100 configured to infuse medicine to a user. In operation 535,the pharmacy may provide one or more medicine cartridges 120 to thecustomer. Also, in operation 540, the pharmacy may provide one or moreinfusion sets 146 to the customer. In one example, the pharmacy canprovide the pump devices 100, medicine cartridges 120, and infusion sets146 as described in association with the transaction 65 described inFIG. 1. In operation 545, the pharmacy submits a payment request to thecustomer's health insurance provider in accordance with the healthinsurance information to receive payment for the portion of the costscovered by the health insurance company.

After a period of time, the process 500 may return to operation 525 inwhich the pharmacy receives a copay payment from the customer with theexpectation of providing the customer with a refill quantity of one ormore of the infusion pumps or other components described in theprescription information. When the customer returns for a refillquantity, the pharmacy can check a customer record to verify that thereis valid prescription information on file and that the maximum refilltime and number of refills have not been exceeded. The pharmacy may alsoverify that the health insurance information remains valid and that thecosts of the refill quantity will be covered by the health insuranceprovider. As described previously in connection with operations 530-540,the pharmacy provides the prescribed components (e.g., one or more pumpdevices 100, one or more fluid cartridges 120, and/or one or moreinfusion sets 146) to the customer as part of the refill transaction. Insome embodiments, after delivering the prescribed components (as inoperations 530-540), the pharmacy updates the customers record toindicate that that a refill quantity has been given (e.g., incrementinga counter representing the number of times the prescription has beenrefilled). The pharmacy may repeat operations 525-540, receiving fromthe customer the required copay payment and providing refill quantitiesto the customer, as long as the maximum refill time period or number ofrefills is not exceeded and the health insurance provider authorizes therefill quantity. After a maximum refill time period or number of refillsis exceeded, the pharmacy may request that the customer submits a newprescription to the pharmacy.

At a subsequent point in time (e.g., at regular intervals, afterdelivering components of the pump system 10 to a customer, when theinventory of one or more components of the pump system 10 become low,and the like) the pharmacy may evaluate the existing inventory.Accordingly, the process 500 may return to operation 505 in which thepharmacy again orders additional quantities of the infusion pumps orother related components. The additional quantities can be used toreplenish the pharmacy inventory.

Referring to now FIG. 16-17, in some embodiments the infusion pumps canbe packaged together with other components in an infusion pump kit 600.The infusion pump kit 600 can include one or more pump devices 100, oneor more medicine cartridges 120, and (optionally) one or more infusionsets 146 that are packaged in predetermined numbers for convenientdistribution to pump users. In this embodiment, the infusion pump kit600 may include a container 640, three pump devices 100, three medicinecartridges 120, and six infusion sets 146. Accordingly, the quantity ofinfusion pumps 100 provided in the container 640 is in a 1:1 ratio withthe quantity of medicine cartridges 120 provided in the container 640.It should be understood that, in other embodiments, the kits 600 caninclude other quantities of pump devices 100 (e.g., 1, 2, 4, and thelike), medicine cartridges 120, and infusion sets 146. For example, thekit 600 can include two pump devices 100, two medicine cartridges 120,and three infusion sets 146.

In some embodiments, the one or more pump devices 100, the one or morefluid cartridges 120, and/or the one or more infusion sets 146 areassembled into the infusion pump kit 600 by a medical device supplierfor shipment to a pharmacy. In alternative embodiments, a pharmacy canreceive the individual components of the pump system 10 from one or moremedical device suppliers and assemble these items into the kit 600 atthe pharmacy for subsequent distribution to customers.

Referring to FIG. 17, the container 640 of the infusion pump kit 600 caninclude separate compartments for storage of the different pump system10 components. In some embodiments, the container 640 includes aninsulated compartment 650 surrounded by thermal insulation 660 formaintaining the three medicine cartridges 120 in a refrigerated statesuitable for storage of medicine during transport. Additionally, thecompartment 650 can include a cold pack 665. The thermal insulation 660and the cold pack 665 can be configured to maintain the medicinecartridges 120 in a refrigerated state during the distribution time tothe pump user. For example, in the embodiments in which the medicinecartridges 120 contain insulin, the thermal insulation 660 and the coldpack 665 can be configured to maintain the medicine cartridges 120 atless than about 55° F., less than about 50° F., less than about 45° F.,between about 33° F. and about 44° F., and preferably between 35° F. and39° F.) In some embodiments, the cold pack 665 may comprise a gel packthat can be cooled by placement in a refrigerator or freezer. Aftercooling, the cold pack 665 can be placed in the compartment 650 to helpmaintain the temperature of the compartment 650 within the desiredrange. In another example, the cold pack 665 can be a chemical packthat, when chemicals inside the pack are mixed, cause the temperature ofthe chemical pack to fall. A second compartment 670 of the container 640can store the pump devices 100. This compartment 670 is not necessarilyinsulated and may remain at ambient temperatures during transport. Insome circumstances, the first and second compartments 650 and 670 mayinclude packaging material such as foam material or bubble-wrap. Thecontainer 640 may also contain a number of infusion sets 146. Theinfusion sets 146 can be arranged in a sealed pouch 680 so as tomaintain the infusion sets 146 in a sterile condition duringdistribution to the pump user. It should be understood that, inalternative embodiments, the container 640 can contain quantities ofpump devices 100, medicine cartridges 120, and (optionally) infusionsets 146 that are different from those quantities depicted in FIGS.16-17.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A method of providing an medicine infusion pumpdevice, comprising: storing multiple infusion pump devices in a pharmacyinventory while refrigerating prefilled medicine cartridges in arefrigeration unit of the pharmacy inventory, the infusion pump devicesbeing configured to irreversibly receive the prefilled medicinecartridges therein; in response to an individual user request to apharmacy for repeated deliveries of infusion pump devices, distributinga plurality of infusion pump devices from the pharmacy inventory to theindividual user while contemporaneously distributing at least a portionof the prefilled medicine cartridges from the pharmacy inventory and aplurality of infusion sets attachable to the infusion pump devices,wherein the prefilled medicine cartridges are external to the infusionpump devices when the infusion pump devices are distributed to theindividual user.
 2. The method of claim 1, wherein the step ofdistributing the plurality of infusion pump devices comprisescontemporaneously distributing the infusion pump devices, the prefilledmedicine cartridges, and the infusion sets in a packaged kit including athermally insulated compartment.
 3. The method of claim 2, wherein thepackaged kit contains the infusion pump devices, the prefilled medicinecartridges, and the infusion sets in a predetermined ratio of 1:1:2respectively, and further contains a cold pack in said insulatedcompartment.
 4. The method of claim 3, further comprising receiving apayment as part of a single transaction when distributing the pluralityof infusion pump devices, the medicine cartridges, and the infusionsets.
 5. A method of providing an medicine infusion pump device,comprising: storing multiple infusion pump devices in a pharmacyinventory while also storing prefilled medicine cartridges in thepharmacy inventory, each of the prefilled medicine cartridges beingsealed by a pierceable septum and being external to the infusion pumpdevices when stored in the pharmacy inventory, each of the infusion pumpdevices including a cap device configured to seal an external opening ofa respective infusion pump device and configured to pierce the septum ofa respective prefilled medicine cartridge after the respective prefilledmedicine cartridge is slidably inserted through said external opening;in response to receiving a prescription indicative of at least infusionpumps for an individual user, contemporaneously distributing from apharmacy a set of said infusion pump devices in a predetermined quantityalong with the same predetermined quantity of said prefilled medicinecartridges from the pharmacy inventory and a plurality of infusion setsattachable to said cap devices of the infusion pump devices, wherein theprefilled medicine cartridges are external to the infusion pump deviceswhen the infusion pump devices are distributed to the individual user.6. The method of claim 5, wherein the step of distributing the pluralityof infusion pump devices comprises contemporaneously distributing thepredetermined quantity of the infusion pump devices, the samepredetermined quantity of the prefilled medicine cartridges, and theinfusion sets in a kit that is equipped with a thermally insulatedcompartment configured to contain at least said predetermined quantityof the prefilled medicine cartridges.
 7. The method of claim 6, whereinthe kit distributed from the pharmacy includes the predeterminedquantity of infusion pump devices, the predetermined quantity ofprefilled medicine cartridges, and the infusion sets in a ratio of 1:1:2respectively.
 8. The method of claim 6, the kit distributed from thepharmacy includes a means for cooling said insulated compartment duringtransport of said kit.
 9. The method of claim 5, further comprisingcontemporaneously receiving a payment on behalf of said individual useras part of a single transaction when distributing the plurality ofinfusion pump devices, the medicine cartridges, and the infusion sets.10. The method of claim 5, wherein each of the infusion pump devices insaid predetermined quantity of infusion pump devices is configured toremovably attach to a reusable controller device having a user interfacedisplay so that any of said infusion pump devices that is attached tosaid reusable controller device is mechanically coupled with the userinterface display of the reusable controller device.
 11. The method ofclaim 10, each of the infusion pump devices in said predeterminedquantity of infusion pump devices is configured to removably attach to areusable controller device such that a first electrical connectorexposed along an exterior of a selected infusion pump device with asecond electrical connector exposed along an exterior of the reusablecontroller device.
 12. The method of claim 5, wherein each of theinfusion pump devices in said predetermined quantity of infusion pumpdevices includes a drive system comprising a rotational motor coupled toa gear system, the drive system being configured to dispense medicinefrom a corresponding one of said predetermined quantity of prefilledmedicine cartridges.
 13. The method of claim 5, further comprisingdistributing a refill set of infusion pump devices from the pharmacy inresponse to receiving a request to refill said prescription for saidindividual user, the refill set of infusion devices beingcontemporaneously distributing from the pharmacy along with a refill setof said prefilled medicine cartridges from the pharmacy inventory and arefill set of the infusion sets.